Approval · Notice of Compliance 34668 · 2025
PYLERA: Notice of Compliance 34668
Issued January 10, 2025
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 34668
- Date
- January 10, 2025
- Company
- Laboratoires Juvise PharmaceuticalsVilleurbanne, --, France
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Replacement of a manufacturing site and/or manufacturer involving production of the drug substance(s) (bismuth subcitrate potassium and tetracycline hydrochloride). Change in the manufacturing process for the drug substance(s).Change in the specification for the drug substance (bismuth subcitrate potassium). Addition of a drug product manufacturing site and/or manufacturer involving production. Addition of a drug product manufacturing site and/or manufacturer involving primary packaging.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PYLERA | Not yet assigned | — |
Medicinal ingredients
- METRONIDAZOLE 125 MG per CAP
- TETRACYCLINE HCL 125 MG per CAP
- BISMUTH SUBCITRATE POTASSIUM 140 MG per CAP